Two workshops will be organised with at least 15 external participants each, from regulatory bodies and expert-level scientific committees related to regulatory bodies, plus additional high-level participants from research and development.
A reflection document will present the outline of the methodology to design intelligent testing strategies, considerations regarding populating the repository and ranking methods according to product and measurand, current observations on CQAs, as well as approaches and structures intended for the DSS. This document will serve both as an internal orientation and as a foundation for interaction with external stakeholders as it will feed into the whitepaper-drafting in WP1.
The draft whitepaper will propose a catalogue of information requirements and needs for harmonisation (e.g. to address borderline products that fall under different legislature in different world regions). It will propose a gap analysis, where scientific state of the art and regulatory practice seem out of step (e.g. present a list of major adversities of administered NBMs described in the scientific literature, that are hard to predict by current standard testing methods). Thirdly the document will propose a heuristic how to assimilate new evidence in reliable and efficient way into regulatory strategies (e.g. which testing methods would deliver information that supports the modeling of an NMB-specific Adverse Outcome Pathway, for example for CARPA ).
Report on the quantitative evaluation of key variables such as apparent permeability through various barriers systems, or uptake kinetics in key cell populations
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Author(s): Christina Giannakou
Published in: 2019